CREST: Carotid Revascularization Endarterectomy Versus Stenting Trial

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT00004732
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS) (NIH), University of Alabama at Birmingham (Other)
• Enrollment: 2,502
• Locations: 115
• Arms: 2
• Duration (Months): 192
• Patients Per Site: 21.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis; Stroke; Carotid Stenosis; Cerebral Infarction; Myocardial Infarction	Procedure: Carotid Endarterectomy (CEA); Device: Carotid Artery Stenting (CAS)	N/A

Detailed Description

The primary aim of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to contrast the relative effectiveness of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) in preventing stroke, myocardial infarction, and death. Stents are medical devices approved and commonly used for treatment of heart disease. The stent that will be used in this trial is the Rapid Exchange(RX) ACCULINK(TM) Carotid Stent System, an elastic-like metal scaffold that is expanded inside a carotid artery to hold the vessel open.

The RX ACCUNET(TM) Embolic Protection System (an umbrella-like device that expands above the narrowed portion of the carotid artery) will be used in conjunction with the RX ACCULINK stent. The RX ACCUNET system is designed to capture embolic material that could break off from the narrowed area in the carotid artery while still allowing blood to flow through the vessel during the procedure. Embolic material could block blood flow to the arteries beyond the narrowing and be harmful to the brain. The RX ACCUNET System is closed and removed after the stent is placed.

CEA involves a neck incision and physical removal of the plaque from the inside of the artery. CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open. Participants will be randomly assigned to undergo either CAS or CEA, and all patients will receive best medical management, which includes treatment with aspirin, treatment of high blood pressure, and treatment of other stroke risk factors. Participants will be followed for up to ten years.

With the simplification of the protocol for long-term follow-up, the focus for secondary outcomes is to assess restenosis and viability of the procedure. Restenosis rates on an annual basis in both the endarterectomy and stenting arms of the study will be assessed using carotid duplex ultrasound exams performed annually (standard of care).

In addition to restenosis, the "viability" of the procedures will be assessed by the need (or lack of need) for repeat revascularization (either open surgical or endovascular) after the index procedure. The question "has a new carotid intervention been performed since last follow-up" will be asked at every contact with the patient. If answered positively, additional data will be collected on the appropriate case report forms(CRFs).

LINKAGE OF CREST COHORT WITH CENTERS FOR MEDICAID AND MEDICARE SERVICES(CMS) ADMINISTRATIVE DATA

The purpose of linking Medicare-eligible CREST participants with CMS data files is to assess patient outcomes and utilization of health care services. This plan to link in- and out-patient episodes of care using national Medicare data establishes a new resource that will enhance current follow-up strategies, as well as explore alternative strategies to ascertain patient outcomes for future clinical studies.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2502 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)
• Study Start Date: Dec 1, 2000
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Carotid Artery Endarterectomy (CEA) Carotid endarterectomy is surgery to remove plaque buildup that causes narrowing (stenosis) in the carotid artery.	Procedure: Carotid Endarterectomy (CEA); CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
Active Comparator: Carotid Artery Stenting (CAS) Carotid artery stenting (CAS) is a procedure used to open narrowed carotid arteries. During the procedure, a small, expandable wire tube called a stent is permanently inserted into the carotid artery.	Device: Carotid Artery Stenting (CAS); CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. A stent is then placed to cover the plaque and hold the artery open. Participants randomized to this arm of the trial were treated using the RX Acculink Carotid Stent with or without the RX Accunet Embolic Protection Device.; Other Names: Angioplasty of carotid artery and stent placement.

Outcome Measures

Primary Outcome Measures

1. Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years. [30 days and 4 years]

   The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (>=50%) or asymptomatic (>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.

Secondary Outcome Measures

1. Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke). [4 years]

   4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Symptomatic patients with recent neurological events (TIA or non-disabling stroke) with an associated carotid stenosis greater than or equal to 50% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 70% by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) are eligible for randomization.

• Asymptomatic patients with no recent (in the last 6 months) neurological events referable to the study with artery and carotid stenosis (patients with symptoms beyond 180 days are considered asymptomatic) greater than or equal to 60% by angiography or greater than or equal to 70% by ultrasound or greater than or equal to 80% by CTA or MRA are eligible for randomization.

Exclusion Criteria:

• Conditions that: (1) interfere with the evaluation of endpoints, (2) are known to interfere with the completion of CEA or CAS, or (3) affect the likelihood of survival for the study period (4 years). Chronic atrial fibrillation and/or anti-coagulation or episodic atrial fibrillation within the last 6 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Dignity Health dba St. Joseph's Hospital & Medical Center	Phoenix	Arizona	United States	85013
3	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85259
4	The Arizona Board of Regents for the University of Arizona	Tucson	Arizona	United States	85724
5	Board of Trustees of the University of Arkansas	Little Rock	Arkansas	United States	72701
6	USC University Hospital & LA County Hospital	Los Angeles	California	United States	90033
7	The Regents of the University of California	Los Angeles	California	United States	90095
8	Kaiser Permanente Medical Center	San Diego	California	United States	92120
9	Northern California Institute for Research and Education	San Francisco	California	United States	94121
10	Catholic Healthcare West	Stockton	California	United States	95204
11	Christiana Care Health Services, Inc.	Newark	Delaware	United States	19718
12	Morton Plant Hospital	Clearwater	Florida	United States	33756
13	Mayo Clinic	Jacksonville	Florida	United States	32224
14	Leesburg Medical Center	Leesburg	Florida	United States	34748
15	Miami Cardiac & Vascular Institute of Baptist Hospital of Miami, Inc.	Miami	Florida	United States	33187
16	Florida Hospital Neuroscience Institute, a division of Adventist Health System/Sunbelt, Inc.	Orlando	Florida	United States	32803
17	Orlando Regional Medical Center	Orlando	Florida	United States	32828
18	University of South Florida Board of Trustees	Tampa	Florida	United States	33606
19	Piedmont Hospital/Fuqua Heart Center	Atlanta	Georgia	United States	30309
20	Emory University	Atlanta	Georgia	United States	30322
21	St. Joseph's of Atlanta	Atlanta	Georgia	United States	30342
22	St. Joseph's Candler Health System	Savannah	Georgia	United States	31405
23	Norwestern Memorial Hospital	Chicago	Illinois	United States	60611
24	Alexian Brothers Specialty Group	Elk Grove Village	Illinois	United States	60007
25	Loyola University of Chicago	Maywood	Illinois	United States	60153
26	Peoria Radiology Research and Education	Peoria	Illinois	United States	61637
27	Prarie Cardiology-St. John's Hospital	Springfield	Illinois	United States	62794
28	Southern Illinois School of Medicine	Springfield	Illinois	United States	62794
29	Central Dupage Hospital	Winfield	Illinois	United States	60190
30	Lutheran Medical Group, LLC,	Fort Wayne	Indiana	United States	46804
31	Parkview Hospital, Inc.	Fort Wayne	Indiana	United States	46805
32	St. Vincent's Hospital	Indianapolis	Indiana	United States	46260
33	Catholic Health Initiatives /Mercy Hospital Center	Des Moines	Iowa	United States	50314
34	Baptist Healthcare System, Inc.	Lexington	Kentucky	United States	40504
35	Vascular Surgery Associates	Baton Rouge	Louisiana	United States	70809
36	Ochsner Foundation Hospital	New Orleans	Louisiana	United States	70121
37	Anne Arundel Health System Research Institute	Annapolis	Maryland	United States	21401
38	Johns Hopkins University	Baltimore	Maryland	United States	21287
39	Adventist Healthcare, Inc.	Takoma Park	Maryland	United States	20912
40	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
41	Steward St. Elizabeth's Medical Center of Boston, Inc.	Boston	Massachusetts	United States	02135
42	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
43	Brigham and Womens Hospital, Inc.	Boston	Massachusetts	United States	02215
44	Cape Cod Health Care, Inc.,	Hyannis	Massachusetts	United States	02601
45	University of Michigan	Ann Arbor	Michigan	United States	48109
46	Henry Ford Health System	Detroit	Michigan	United States	48202
47	St. John Hospital and Medical Center	Detroit	Michigan	United States	48236
48	Michigan Vascular Research Center	Flint	Michigan	United States	48507
49	Spectrum Health Hospital	Grand Rapids	Michigan	United States	49503
50	William Beaumont Hospital	Royal Oak	Michigan	United States	48075
51	Providence St. John Hopital	Southfield	Michigan	United States	48075
52	Michigan Heart & Vascular Institute/St. Joseph's Mercy Hospital	Ypsilanti	Michigan	United States	48197
53	North Memorial Health Care	Robbinsdale	Minnesota	United States	55422
54	Mayo Clinic Rochester/St. Mary's	Rochester	Minnesota	United States	55905
55	Mississippi Baptist Medical Center, Inc.	Jackson	Mississippi	United States	39202
56	Heartland Physician Services, LLC	Kansas City	Missouri	United States	64114
57	Mercy Hospitals East Communities	St. Louis	Missouri	United States	63141
58	St. Patrick's Hospital International Heart Institute of MT	Missoula	Montana	United States	59802
59	Dartmouth College and the constituent members of DARTMOUTH HITCHCOCK MEDICAL CENTER	Lebanon	New Hampshire	United States	03756
60	St. Michael's Medical Center	Newark	New Jersey	United States	07013
61	Center for Vascular Awareness, Inc.	Albany	New York	United States	12208
62	Millard Fillmore SUNY Buffalo	Buffalo	New York	United States	14209
63	NYU School of Medicine	New York	New York	United States	10016
64	The Feinstein Institute for Medical Research	New York	New York	United States	10021
65	Weill Medical College of Cornell University	New York	New York	United States	10021
66	Columbia Presbyterian	New York	New York	United States	10032
67	St. Francis Hospital	Port Washington	New York	United States	11050
68	University of Rochester	Rochester	New York	United States	14642
69	Richmond University Medical Center	Staten Island	New York	United States	10310
70	Westchester Medical Center	Valhalla	New York	United States	10595
71	UNC at Chapel Hill	Chapel Hill	North Carolina	United States	27599
72	The Charlotte-Mecklenburg Hospital Authority	Charlotte	North Carolina	United States	28203
73	Duke University Medical Center	Durham	North Carolina	United States	27710
74	Forsyth Radiological Associates	Winston-Salem	North Carolina	United States	27103
75	Wake Forest University	Winston-Salem	North Carolina	United States	27157
76	Christ Hospital	Cincinnati	Ohio	United States	45219
77	University of Cincinnati	Cincinnati	Ohio	United States	45267
78	The Cleveland Clinic Lerner College Of Medicine of CWRU	Cleveland	Ohio	United States	44195
79	Midwest Ohio Health Research Institute	Columbus	Ohio	United States	43214
80	The Toledo Hospital	Toledo	Ohio	United States	43606
81	University of Toledo	Toledo	Ohio	United States	43614
82	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma	United States	73120
83	Rogue Valley Medical Center	Medford	Oregon	United States	97504
84	Oregon Health Science University	Portland	Oregon	United States	97201
85	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18105
86	Heritage Valley Medical Group	Beaver	Pennsylvania	United States	15009
87	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
88	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
89	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
90	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania	United States	15212
91	UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania	United States	15232
92	Rhode Island Hospital	Providence	Rhode Island	United States	02903
93	South Carolina Heart Center	Columbia	South Carolina	United States	29204
94	Metro Knoxville HMA	Knoxville	Tennessee	United States	37920
95	Baptist Memorial Hospital	Memphis	Tennessee	United States	38120
96	The University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75390
97	Houston Methodist Hospital	Houston	Texas	United States	77030
98	UT Houston Memorial	Houston	Texas	United States	77030
99	Scott & White Memorial Hospital	Temple	Texas	United States	76508
100	Intermountain Health Services	Salt Lake City	Utah	United States	84143
101	University of Virginia	Charlottesville	Virginia	United States	22908
102	Swedish Health Services	Seattle	Washington	United States	98122
103	Providence Health & Services - Washington	Spokane	Washington	United States	99204
104	Charleston Area Medical Center	Charleston	West Virginia	United States	25304
105	Marshfield Clinic	Marshfield	Wisconsin	United States	54449
106	St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
107	Governors of the University of Calgary and the Calgary Health Region	Calgary	Alberta	Canada	T2N 2T9
108	The University of British Columbia and The Vancouver Coastal Health Authority	Vancouver	British Columbia	Canada	V5Z 3J5
109	St. Boniface General Hospital	Winnipeg	Manitoba	Canada	R2H2A6
110	The Credit Valley Hospital and Trillium Health Centre	Mississauga	Ontario	Canada	L5B 4A2
111	Ottawa Hospital Research Institute	Ottawa	Ontario	Canada	K1H1A2
112	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
113	University Health Network	Toronto	Ontario	Canada	M5T 2S8
114	Lawson Health Research Institute	Toronto	Ontario	Canada	N6A5A5
115	CHU de Québec	Quebec City	Quebec	Canada	G1J1Z4

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• National Institute of Neurological Disorders and Stroke (NINDS)
• University of Alabama at Birmingham

Investigators

• Principal Investigator: Thomas G. Brott, M.D., Mayo Clinic and Rutgers University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hobson RW 2nd, Brott T, Ferguson R, Roubin G, Moore W, Kuntz R, Howard G, Ferguson J. CREST: carotid revascularization endarterectomy versus stent trial. Cardiovasc Surg. 1997 Oct;5(5):457-8.
• Hobson RW 2nd, Brott TG, Roubin GS, Silver FL, Barnett HJ. Carotid artery stenting: meeting the recruitment challenge of a clinical trial. Stroke. 2005 Jun;36(6):1314-5. Epub 2005 Apr 28.
• Hobson RW 2nd, Howard VJ, Brott TG, Howard G, Roubin GS, Ferguson RD; For the CREST Executive Committee . Organizing the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): National Institutes of Health, Health Care Financing Administration, and industry funding. Curr Control Trials Cardiovasc Med. 2001 Jul 13;2(4):160-164.
• Hobson RW 2nd, Howard VJ, Roubin GS, Brott TG, Ferguson RD, Popma JJ, Graham DL, Howard G; CREST Investigators. Carotid artery stenting is associated with increased complications in octogenarians: 30-day stroke and death rates in the CREST lead-in phase. J Vasc Surg. 2004 Dec;40(6):1106-11.
• Hobson RW 2nd, Howard VJ, Roubin GS, Ferguson RD, Brott TG, Howard G, Sheffet AJ, Roberts J, Hopkins LN, Moore WS; CREST. Credentialing of surgeons as interventionalists for carotid artery stenting: experience from the lead-in phase of CREST. J Vasc Surg. 2004 Nov;40(5):952-7.
• Hopkins LN, Roubin GS, Chakhtoura EY, Gray WA, Ferguson RD, Katzen BT, Rosenfield K, Goldstein J, Cutlip DE, Morrish W, Lal BK, Sheffet AJ, Tom M, Hughes S, Voeks J, Kathir K, Meschia JF, Hobson RW 2nd, Brott TG. The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase. J Stroke Cerebrovasc Dis. 2010 Mar;19(2):153-62. doi: 10.1016/j.jstrokecerebrovasdis.2010.01.001.
• Howard VJ, Voeks JH, Lutsep HL, Mackey A, Milot G, Sam AD 2nd, Tom M, Hughes SE, Sheffet AJ, Longbottom M, Avery JB, Hobson RW 2nd, Brott TG. Does sex matter? Thirty-day stroke and death rates after carotid artery stenting in women versus men: results from the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) lead-in phase. Stroke. 2009 Apr;40(4):1140-7. doi: 10.1161/STROKEAHA.108.541847. Epub 2009 Feb 10.
• Lal BK, Brott TG. The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results. J Vasc Surg. 2009 Nov;50(5):1224-31. doi: 10.1016/j.jvs.2009.09.003.
• Sheffet AJ, Roubin G, Howard G, Howard V, Moore W, Meschia JF, Hobson RW 2nd, Brott TG. Design of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST). Int J Stroke. 2010 Feb;5(1):40-6. doi: 10.1111/j.1747-4949.2009.00405.x.

• Responsible Party: Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT00004732
• Other Study ID Numbers: 0119970017; R01NS038384
• First Posted: Feb 28, 2000
• Last Update Posted: May 17, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Rutgers, The State University of New Jersey: angioplasty; asymptomatic; atherosclerosis; carotid endarterectomy; carotid stenting; CREST; Cerebral Infarction; device; intervention; restenosis; revascularization; stenosis; stent; stroke; symptomatic; surgery; transient ischemic attack
• Additional relevant MeSH terms: Cerebral Infarction; Carotid Stenosis; Myocardial Infarction; Atherosclerosis; Infarction

Study Results

Participant Flow

Arm/Group Title	Carotid-Artery Stenting (CAS)	Carotid Endarterectomy (CEA)
Arm/Group Description	CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open.	CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
Period Title: Overall Study
STARTED	1262	1240
COMPLETED	1193	1129
NOT COMPLETED	69	111

Baseline Characteristics

Arm/Group Title	Carotid-Artery Stenting	Carotid Endarterectomy	Total
Arm/Group Description	Patients Randomized to CAS	Patients Randomized to CEA	Total of all reporting groups
Overall Participants	1262	1240	2502
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.9 (9.0)	69.2 (8.7)	69.0 (8.9)
Sex: Female, Male (Count of Participants)
Female	455 36.1%	417 33.6%	872 34.9%
Male	807 63.9%	823 66.4%	1630 65.1%
Race/Ethnicity, Customized (Number) [Number]
White	1172 92.9%	1160 93.5%	2332 93.2%
Non-White	81 6.4%	71 5.7%	152 6.1%
Not Specified	9 0.7%	9 0.7%	18 0.7%
Symptomatic Status (Number) [Number]
Asymptomatic	594 47.1%	587 47.3%	1181 47.2%
Symptomatic	668 52.9%	653 52.7%	1321 52.8%
Baseline Hypertension (Number) [Number]
Yes	1080 85.6%	1061 85.6%	2141 85.6%
No	179 14.2%	172 13.9%	351 14%
Unknown	3 0.2%	7 0.6%	10 0.4%
Diabetes Status (Number) [Number]
Yes	384 30.4%	375 30.2%	759 30.3%
No	873 69.2%	857 69.1%	1730 69.1%
Unknown	5 0.4%	8 0.6%	13 0.5%
Dyslipidemia (Number) [Number]
Yes	1040 82.4%	1053 84.9%	2093 83.7%
No	214 17%	174 14%	388 15.5%
Unknown	8 0.6%	13 1%	21 0.8%
Present Smoker (Participant) [Number]
Yes	329	317	646
No	915	899	1814
Unknown	18	24	42
Lesion Location (Number) [Number]
Left	639 50.6%	648 52.3%	1287 51.4%
Right	623 49.4%	592 47.7%	1215 48.6%
Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	141.6 (20.2)	141.2 (20.5)	141.4 (20.3)
Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	74.0 (11.6)	73.9 (11.5)	74.0 (11.5)
Percent Stenosis at Randomization (Number) [Number]
Moderate (<70%)	165 13.1%	186 15%	351 14%
Severe (>=70%)	1097 86.9%	1054 85%	2151 86%

Outcome Measures

1. Primary Outcome

Title	Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.
Description	The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (>=50%) or asymptomatic (>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
Time Frame	30 days and 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid-Artery Stenting	Carotid Endarterectomy
Arm/Group Description	Patients Randomized to CAS	Patients Randomized to CEA
Measure Participants	1262	1240
Mean (Standard Error) [Percentage]	7.2 (0.8)	6.8 (0.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Carotid-Artery Stenting, Carotid Endarterectomy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments	HR (95% CI) adjusted for age, sex and symptomatic status

2. Secondary Outcome

Title	Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).
Description	4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid-Artery Stenting	Carotid Endarterectomy
Arm/Group Description	Patients randomized to CAS	Patients randomized to CEA
Measure Participants	1262	1240
Men	6.2 (0.9)	6.8 (1.0)
Women	8.9 (1.4)	6.7 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Carotid-Artery Stenting, Carotid Endarterectomy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.35
	Confidence Interval	(2-Sided) 95%; 0.82 to 2.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	HR (95% CI) for WOMEN CAS vs CEA (adjusted for age and symptomatic status)

Adverse Events

Time Frame	Periprocedural period
Arm/Group Title	Carotid-Artery Stenting		Carotid Endarterectomy
Arm/Group Description	Patients Randomized to CAS		Patients Randomized to CEA
All Cause Mortality
	Carotid-Artery Stenting		Carotid Endarterectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Carotid-Artery Stenting		Carotid Endarterectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	322/1262 (25.5%)		292/1240 (23.5%)
Blood and lymphatic system disorders
Hemodynamic SAE	73/1262 (5.8%)	80	56/1240 (4.5%)	63
Cardiac disorders
Cardiovascular SAE	36/1262 (2.9%)	41	49/1240 (4%)	58
General disorders
Miscellaneous SAE	43/1262 (3.4%)	50	47/1240 (3.8%)	72
Other SAE	1/1262 (0.1%)	1	0/1240 (0%)	0
Infections and infestations
Infectious Disorder SAE	27/1262 (2.1%)	31	19/1240 (1.5%)	19
Metabolism and nutrition disorders
Metabolic/Electrolyte SAE	4/1262 (0.3%)	4	4/1240 (0.3%)	4
Nervous system disorders
Neurologic SAE	98/1262 (7.8%)	124	93/1240 (7.5%)	108
Surgical and medical procedures
Angiographic/Procedural SAE	9/1262 (0.7%)	10	9/1240 (0.7%)	11
Vascular disorders
Hemorrhagic/Vascular SAE	32/1262 (2.5%)	40	40/1240 (3.2%)	53
Other (Not Including Serious) Adverse Events
	Carotid-Artery Stenting		Carotid Endarterectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	213/1262 (16.9%)		212/1240 (17.1%)
Blood and lymphatic system disorders
Hemodynamic AE (not serious)	65/1262 (5.2%)	73	45/1240 (3.6%)	50
Cardiac disorders
Cardiovascular AE (non-endpoint, non-serious)	34/1262 (2.7%)	41	36/1240 (2.9%)	42
General disorders
Other AE (not serious)	0/1262 (0%)	0	1/1240 (0.1%)	1
Miscellaneous Types of AEs (not serious)	83/1262 (6.6%)	132	86/1240 (6.9%)	127
Infections and infestations
Infectious Disorder AE (not serious)	13/1262 (1%)	13	12/1240 (1%)	13
Metabolism and nutrition disorders
Metabolic/Electrolyte AE (not serious)	8/1262 (0.6%)	8	4/1240 (0.3%)	4
Nervous system disorders
Neurologic AE (non-endpoint, non-serious)	65/1262 (5.2%)	81	72/1240 (5.8%)	83
Neurologic AE (endpoint, non-serious)	1/1262 (0.1%)	1	0/1240 (0%)	0
Surgical and medical procedures
Angiographic/Procedural AE (not serious)	24/1262 (1.9%)	27	43/1240 (3.5%)	49
Vascular disorders
Hemorrhagic/vascular AE (not serious)	21/1262 (1.7%)	23	20/1240 (1.6%)	23

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.